Conduct Decentralized Clinical Trials in Africa
Decentralization is the future of clinical research. Partner with industry experts at Infiuss Health to make your African decentralized clinical trial a success. We have an active database of thousands of patients in various therapeutic areas all across Africa, and collaborate with local clinics, local labs and mobile medical professionals, for the smooth conduct and implementation of decentralized clinical trials.
What Is a Decentralized Clinical Trial?
A decentralized clinical trial is a clinical trial model that occurs in a distributed setting, as opposed to at a single site.
The entire process—patient recruitment, the administration of study devices or drugs, and clinical data management—all happen remotely and are managed by a clinical trial service provider, such as Infiuss Health.
Decentralized Clinical Trials FDA Definition
The Food and Drug Administration defines decentralized trials as those executed through telemedicine and mobile/local healthcare providers, using processes and technologies that differ from the traditional clinical trial model.
When defining decentralized clinical trials (DCT), the FDA stresses that DCTs hold promise to reduce patient and sponsor burden and increase accrual and retention of a more diverse trial population.Through this definition, the FDA put an emphasis on inclusivity of a diverse trial population and a patient-centric approach, brought about by the clinical trial going to the patient.
Inclusivity is often more difficult to achieve in centralized, traditional clinical trials as patients are required to go to sites for IP and medical device administration.By decentralizing the trial process, DCTs succeed at improving patient diversity and inclusion of trial participants of various backgrounds and ethnicities. Patients in rural settings, that would normally not be able to participate in clinical trials due to proximity (or the lack thereof) to sites, can participate in a decentralized clinical trial model.
What Are the Key Elements of Decentralized Trials?
The four key elements of an effective decentralized trial are:
1. Incorporating Patient Insights
Decentralized trials are patient centric, so the key to a high-quality trial is patient engagement.
The principal investigator of a decentralized trial should be skilled at improving clinical trial participation among patients, collecting remote patient experiences (via validated questionnaires and electronic clinical outcomes assessments), and reporting crucial data to the sponsor.
2. Integrating New Technologies for a Seamless Process
Clinical trial monitoring in a decentralized study requires knowledge of crucial technologies that are put in place to make the remote monitoring process seamless.
Keeping up to date with the newest technologies is essential for a successful DCT. Mastering online clinical trial management systems—understanding their nuances and knowing how to use them effectively—is one of the most important skills of a PI and other site staff in a decentralized trial.
3. Using Quality Data
Just like with traditional trials, the success of a decentralized trial depends on the quality of the collected data.
Sponsors should look for a CRO partner with extensive experience in quality data collection. At Infiuss, we utilize the newest electronic data capture technologies in our PROBE platform, and our PIs have extensive knowledge of data collection and data quality control.
4. Selecting an Optimal Delivery Strategy
Due to the physical distance between the patients and the trial site, trial site visits tend to be virtual in a decentralized trial.
That’s why communication between the sponsor and the CRO is key. A CRO should have a delivery strategy put in place that quickly, clearly, and concisely delivers crucial information to the sponsor.
Additional Elements of DCT
Some additional attributes and benefits of decentralized clinical trials potentially include the following:
Improved experiences for patients
Development of precision medicine at a reduced cost
Ability to conduct clinical research in regions where centralized trials would be difficult or impossible
If you are considering a DCT for your clinical research, talk to us about how we can help!
What Are the Types of Clinical Trials?
When it comes to approaches to clinical trial design, there are three main types of clinical trials:
- Centralized clinical trials
- Decentralized clinical trials
- Hybrid clinical trials
In centralized trials, the whole process happens in or near a single hospital site. Decentralized trials happen in a distributed fashion, with data collected from patients’ homes or from a variety of sites. Hybrid trials combine the benefits of these two types, with a mix of centralized and decentralized components.
Centralized Trials vs Decentralized Trials vs Hybrid Trials
Centralized vs Decentralized Clinical Trials
Following site selection, a site initiation letter is sent to the site, detailing the date and time of the site initiation visit (SIV), including the agenda and the list of site staff that are required to be in attendance. The principal investigator, any subinvestigator, pharmacist, research nurse and lab personnel must be present at the SIV. During the SIV, the site is prepared for study conduct in the following ways:
Virtual clinical trial visits from virtual doctors,
Home visits from mobile nurses and physicians for data collection
Electronically obtaining informed consent
Online study training
The use of telemedicine and online wearables for data collection & transfer and
The use of electronic clinical outcomes assessments and online validated questionnaires to document the patient's experience.
Infiuss has extensive experience with centralized, decentralized and hybrid clinical trials. For centralized clinical trials to be successful, trial site management must be exceptional. We collaborate with sponsors to select the ideal site for their research needs and monitor the site throughout the trial process.
For decentralized trials, our experts will help sponsors recruit patients that fit the requirements of their clinical trial. We also collect trial data and send crucial information to sponsors quickly and efficiently.
What Is a Hybrid Clinical Trial?
A hybrid approach to clinical trials combines aspects of traditional, centralized trials with some aspects of decentralized trials to generate real-world evidence of a proposed treatment or device.
Hybrid trials typically start like traditional trials, with participants randomized to different groups based on their medical record, age, gender, and other qualifiers.
The second part of a hybrid clinical trial is usually decentralized. Participants are instructed to continue with their usual daily activities while incorporating the studied medical device or drug into it and reporting on the results.
Why Are Trials Decentralized?
There are an array of benefits to having your trial decentralized. Some of the reasons more and more trials are decentralized are:
Faster patient recruitment
Increased patient diversity
Higher retention rates among participants
Improved data accuracy
Easier analysis and reporting of results
Why Conduct Clinical Trials in Africa?
A technology-first approach to research. We are your foot on the ground in Africa.
Access
Traditionally, Africa has not been particularly accessible to American and European researchers. We’re changing that, with the provision of quality clinical research for easy access to African research sites and participants.
Cost
Our pharmaceutical & academic partners conduct clinical trials in Africa for a fraction of the cost they would spend in other geographic regions.
Genetic Diversity
The African population exhibits greater genetic diversity than the rest of the world combined. Obtaining safety and efficacy data in clinical trials from populations with broader genetic diversity is essential for data integrity and generalizable results.
Endemic Diseases
If you’re researching rare diseases endemic to the African continent (e.g., malaria, ebola, sickle cell anemia, hantavirus or monkeypox), you’ll want to conduct your clinical trials in Africa.
FAQ on Decentralized Trials
Beyond decentralized trials, Infiuss is your African CRO partner for all clinical trial needs. From patient recruitment to clinical data management, pharmacovigilance to site management, we will partner with you for all types of clinical research.
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